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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02833051
Other study ID # EnergyBalance01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2015
Est. completion date November 2015

Study information

Verified date January 2021
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this project is to examine the effects of an acute bout of exercise on children's energy intake over the course of a day. Previous studies in adolescents and adults have shown exercise to be effective in decreasing short-term energy intake, with some variability. Individual characteristics such as habitual physical activity and psychological factors may influence the effect of exercise on energy intake, but these factors have yet to be examined. The investigators have assembled a multi-disciplinary team of researchers, with expertise in eating behavior, exercise, psychology, and clinical research in order to examine these questions. First, the investigators will examine the difference in energy intake at lunch, snack, and dinner meals in response to 30 minutes of imposed exercise compared to 30 minutes of rest. Second, the investigators will collect objective measures of children's habitual physical activity, child characteristics (body composition, eating behavior traits), and individual responses to the controlled exercise bout. The investigators can then examine both group and individual differences in the energy intake response to exercise. Children (ages 9-12) will be tested over the course of three visits. The key outcome will be differences in energy intake in response to exercise vs. rest. Secondary outcomes include the influence of differences in habitual physical activity, personal characteristics, and responses to the exercise bout on children's energy intake. The long term goal of this line of research is to understand the mechanisms behind the interaction between exercise and energy intake. The translational potential of this research will be to inform personalized childhood obesity prevention strategies in children at risk for overweight.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 12 Years
Eligibility Inclusion Criteria: - English as a native language - Reading at/above grade level - Generally healthy - Child is "normal weight" below the 85% age- and sex-specific BMI percentile - Child has at least one biological parent classified as "overweight" or "obese" (= 25 kg/m^2) - Regularly eats breakfast Exclusion Criteria: - Contraindications to exercise testing (as defined by the American College of Sports Medicine) - Medical conditions - Psychiatric conditions - Participation in competitive sports teams (year-round or more than 3 practices / week) - Food allergies or other dietary restrictions

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States The Pennsylvania State University University Park Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Liking of foods Ratings of how much child likes specific foods used in the study test meals, completed on visual analog scales Collected at week 1 and 2 of the study
Other Wanting of foods Ratings of how much child wants to eat specific foods used in the study test meals, completed on visual analog scales Collected at week 1 and 2 of the study
Other Fullness feelings Ratings of how full the child feels on a child friendly visual analog scale Collected at multiple time points during weeks 1, 2, and 3
Other Height Height in cm measured by stadiometer Collected at week 1
Other Weight Weight in kg by standard digital scale Collected at week 1
Other Body fat percentage Assessed by bioelectrical impedance analysis scale Collected at week 1
Other Body mass index Calculated from height and weight (kg/m^2) Collected at week 1
Other BMI percentile Calculated from height, weight, age, sex Collected at week 1
Other BMI z-score Calculated from height, weight, age, sex Collected at week 1
Other Fat mass index Calculated from body fat percentage, weight, height Collected at week 1
Other Fat-free mass index Calculated from fat mass, weight, height Collected at week 1
Other Appetitive traits Parent-reported questionnaire of habitual eating styles in children Collected at week 1
Other Pubertal development Parent-reported questionnaire Collected at week 1
Other Family demographics Parent-reported questionnaire Collected at week 1
Primary Baseline energy intake Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information. Collected at week 1 of the study
Primary Energy intake following exercise Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information. Collected at week 2 or 3 (randomized) of the study
Primary Energy intake following sedentary control Food intake is measured at objective laboratory test-meals as the difference between the pre-meal and post-meal weights of individual food items served. Weight of food is converted to energy in kilocalories based on nutrition facts label information. Collected at week 2 or 3 (randomized) of the study
Primary Activity-related energy expenditure - Baseline day Measured using ActiGraph accelerometers Collected in the laboratory at week 1, 2, and 3, and at home for one week between the 2nd and 3rd laboratory visits
Primary Activity-related energy expenditure - Exercise day Measured using ActiGraph accelerometers Collected at week 2 or 3 (randomized) of the study
Primary Activity-related energy expenditure - Sedentary control day Measured using ActiGraph accelerometers Collected at week 2 or 3 (randomized) of the study
Secondary Baseline submaximal fitness test performance YMCA submaximal cycle ergometer test - American College of Sports Medicine Collected at week 1 of the study
Secondary Exercise test performance (70% intensity) - Heart rate Measured by Polar Heart Rate Monitor Collected at week 2 or 3 (randomized) of the study
Secondary Exercise test performance (70% intensity) - Blood pressure Measured by registered nurse or trained research assistant Collected at week 2 or 3 (randomized) of the study
Secondary Exercise test performance (70% intensity) - Ratings of perceived exertion Measured on the Borg Scale Collected at week 2 or 3 (randomized) of the study
Secondary Exercise test performance (70% intensity) - Completion Children's completion of the full 30 minutes of 70% intensity exercise Collected at week 2 or 3 (randomized) of the study
Secondary Child sleep patterns Measured using ActiGraph accelerometers Collected at home for one week between the 2nd and 3rd laboratory visits
Secondary Child physical activity patterns Measured using ActiGraph accelerometers Collected at home for one week between the 2nd and 3rd laboratory visits
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